Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K242483
Device Name Genesys Spine AIS-C II Cervical Interbody Fusion System
Applicant
Genesys Spine
1250 S. Capital Of Texas Highway
Bldg. 3, Suite 600
Austin,  TX  78746
Applicant Contact Derek Southard
Correspondent
Genesys Spine
1250 S. Capital Of Texas Highway
Bldg. 3, Suite 600
Austin,  TX  78746
Correspondent Contact Bill Sowers
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received08/21/2024
Decision Date 02/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-